Linagliptin approved by FDA for treatment of Type 2 diabetes

Abstract

MedWire News: The US Food and Drug Administration (FDA) has approved the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin for treatment of Type 2 diabetes.

Linagliptin is the most recent of three drugs in this class to be approved by the FDA; sitagliptin was the first to be approved in 2006 followed by saxagliptin in 2009.

Advertisement

The approval follows publication of several studies demonstrating linagliptin's efficacy and tolerability, as previously reported by MedWire News.

Linagliptin can be prescribed as a monotherapy or in combination with other commonly used oral antidiabetes drugs such as metformin, sulfonylureas, or pioglitazone.

In the trials leading up to its approval linagliptin was shown to reduce glycated hemoglobin (HbA1c) by up to 0.7% in patients with Type 2 diabetes when used as a monotherapy in comparison to placebo.

When used in combination with metformin, a sulfonylurea, metformin plus a sulfonylurea, or pioglitazone, linagliptin produced significant reductions in HbA1c of 0.6%, 0.5%, 0.6%, and 0.5%, respectively, when compared with placebo.

Advertisement

As with other DPP-4 inhibitors, linagliptin does not increase body weight compared with placebo. There is some evidence to suggest that it can decrease body weight to a small but significant degree (around 1-2 kg) compared with placebo, whereas more traditional antidiabetes drugs such as the sulfonylureas are known to increase body weight.